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Treximet ™ Pharmacy Budget Impact Model Database Validation Study

Treximet ™ Pharmacy Budget Impact Model Database Validation Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01332500
Enrollment
61737
Registered
2011-04-11
Start date
2009-07-31
Completion date
2010-03-31
Last updated
2017-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders

Keywords

Triptans, Migraine

Brief summary

The purpose of this retrospective claims database study was to compare the change in migraine-related prescription (i.e. NSAIDs, Opioids, Ergots) utilization among migraine suffers following initiation of Treximet ™ (sumatriptan/naproxen) compared with subjects initiating treatment with other orally available triptans. The study was used to validate the migraine-related prescription utilization patterns predicted by the Treximet ™ Budget Impact Model. The SourceLx dataset from the family of Wolters Kluwer databases was used for this analysis. The database contains 30% of prescription claims filled in the United States (US), approximately 160 million patient lives. The data has broad representative coverage at both the geographic and payment levels.

Interventions

DRUGSumatriptan/Naproxen combination

Sumatriptan and Naproxen Sodium

DRUGother oral triptans

almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* At least one prescription claim for either Treximet ™ or orally administered triptan * at least 18 years of age at index Rx date * at least one prescription claim for any medication in the pre- and post-index period (proxy for continuous enrollment)

Exclusion criteria

* Subjects receiving nasal sumatriptan at any time * Subjects over 65 years of age

Design outcomes

Primary

MeasureTime frameDescription
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.
Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).
Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.
Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.

Participant flow

Participants by arm

ArmCount
Naïve - Sumatriptan/Naproxen Sodium
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
13,257
Naïve - Oral Triptan
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
39,771
Switch - Sumatriptan/Naproxen Sodium
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
2,903
Switch - Oral Triptan
Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
5,806
Total61,737

Baseline characteristics

CharacteristicNaïve - Sumatriptan/Naproxen SodiumTotalSwitch - Oral TriptanSwitch - Sumatriptan/Naproxen SodiumNaïve - Oral Triptan
Age, Customized
18-30 years old
2889 Participants13246 Participants1026 Participants464 Participants8867 Participants
Age, Customized
31-40 years old
3425 Participants15517 Participants1251 Participants669 Participants10172 Participants
Age, Customized
41-50 years old
3700 Participants17293 Participants1763 Participants943 Participants10887 Participants
Age, Customized
51-60 years old
2315 Participants11181 Participants1263 Participants610 Participants6993 Participants
Age, Customized
61-70 years old
758 Participants3745 Participants428 Participants191 Participants2368 Participants
Age, Customized
>70 years old
170 Participants755 Participants75 Participants26 Participants484 Participants
Sex: Female, Male
Female
11108 Participants52082 Participants5078 Participants2525 Participants33371 Participants
Sex: Female, Male
Male
2149 Participants9655 Participants728 Participants378 Participants6400 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

Primary

Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis

Health plan cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.

Time frame: 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)

Population: The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.

ArmMeasureGroupValue (MEAN)Dispersion
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisNon-steroidal anti-inflammatory drugs9 United States dollarsStandard Deviation 62.3
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisErgots2 United States dollarsStandard Deviation 33.1
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisTriptans284 United States dollarsStandard Deviation 366.1
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisOther0 United States dollarsStandard Deviation 5.1
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisOpioids38 United States dollarsStandard Deviation 609.7
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisTotal332 United States dollarsStandard Deviation 732.1
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisOpioids43 United States dollarsStandard Deviation 477.6
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisTriptans333 United States dollarsStandard Deviation 393.7
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisNon-steroidal anti-inflammatory drugs9 United States dollarsStandard Deviation 62.5
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisTotal387 United States dollarsStandard Deviation 645.4
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisErgots2 United States dollarsStandard Deviation 51.2
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisOther0 United States dollarsStandard Deviation 4.8
p-value: <0.001paired t-test 2-sided
p-value: 0.349paired t-test 2-sided
p-value: 0.208paired t-test 2-sided
p-value: 0.239paired t-test 2-sided
p-value: 0.583paired t-test 2-sided
p-value: <0.001paired t-test 2-sided
Primary

Mean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis

Health Pan Cost was defined as the pharmacy costs. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy costs were calculated as the mean of the total costs of the five drug categories.

Time frame: 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)

Population: The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.

ArmMeasureGroupValue (MEAN)Dispersion
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisTotal433 United States dollarsStandard Deviation 507.4
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisNon-steroidal anti-inflammatory drugs8 United States dollarsStandard Deviation 52.5
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisOther0 United States dollarsStandard Deviation 6.7
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisOpioids47 United States dollarsStandard Deviation 317.8
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisTriptans375 United States dollarsStandard Deviation 374.5
Naïve - Sumatriptan/Naproxen SodiumMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisErgots3 United States dollarsStandard Deviation 48.9
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisTriptans425 United States dollarsStandard Deviation 413.3
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisOther0 United States dollarsStandard Deviation 3.9
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisTotal490 United States dollarsStandard Deviation 695.8
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisErgots3 United States dollarsStandard Deviation 50.1
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisNon-steroidal anti-inflammatory drugs10 United States dollarsStandard Deviation 67.2
Naïve - Oral TriptanMean Health Plan Cost Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisOpioids51 United States dollarsStandard Deviation 522.9
p-value: <0.001paired t-test 2-sided
p-value: 0.054paired t-test 2-sided
p-value: 0.59paired t-test 2-sided
p-value: 0.382paired t-test 2-sided
p-value: 0.343paired t-test 2-sided
p-value: <0.001paired t-test 2-sided
Primary

Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve Analysis

The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents acetaminophen (APAP)/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).

Time frame: 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)

Population: The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.

ArmMeasureGroupValue (MEAN)Dispersion
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisNon-steroidal anti-inflammatory drugs19.2 tablets per participantStandard Deviation 57.1
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisErgots0.1 tablets per participantStandard Deviation 3.6
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisOpioids75.8 tablets per participantStandard Deviation 219
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisOther1.5 tablets per participantStandard Deviation 17
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisTriptans17.7 tablets per participantStandard Deviation 16.3
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisOther1.4 tablets per participantStandard Deviation 13.9
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisTriptans18.4 tablets per participantStandard Deviation 18.2
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisNon-steroidal anti-inflammatory drugs21.5 tablets per participantStandard Deviation 64.9
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisOpioids80.1 tablets per participantStandard Deviation 235.8
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-naïve AnalysisErgots0.1 tablets per participantStandard Deviation 2.4
p-value: 0.162paired t-test 2-sided
p-value: <0.001paired t-test 2-sided
p-value: <0.001paired t-test 2-sided
p-value: 0.005paired t-test 2-sided
p-value: 0.336paired t-test 2-sided
Primary

Mean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch Analysis

The mean number of tablets per participant was computed using prescription fills dispensed in the 6-month follow-up period. Other represents APAP/isometheptene/dichlorphenazone and APAP/isometheptene/caffeine, for example. The number of tablets dispensed was obtained from the quantity dispensed field in the claims data. Triptan tablets were classified as index and non-index medication (if a different oral triptan was filled from that of the index medication); only oral triptans were considered (i.e., excluded injectable triptans).

Time frame: 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)

Population: The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.

ArmMeasureGroupValue (MEAN)Dispersion
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisNon-steroidal anti-inflammatory drugs20.9 tablets per participantStandard Deviation 62.5
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisErgots0.0 tablets per participantStandard Deviation 1.6
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisOpioids88.4 tablets per participantStandard Deviation 254.7
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisOther1.4 tablets per participantStandard Deviation 14.9
Naïve - Sumatriptan/Naproxen SodiumMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisTriptans24.4 tablets per participantStandard Deviation 20.7
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisOther1.3 tablets per participantStandard Deviation 12.1
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisTriptans24.4 tablets per participantStandard Deviation 20.2
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisNon-steroidal anti-inflammatory drugs22.9 tablets per participantStandard Deviation 70.9
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisOpioids87.4 tablets per participantStandard Deviation 255.7
Naïve - Oral TriptanMean Number of Triptan Tablets Per Participant in 6-month Follow-up Period: Treatment-switch AnalysisErgots0.1 tablets per participantStandard Deviation 3.7
p-value: 0.866paired t-test 2-sided
p-value: 0.094paired t-test 2-sided
p-value: 0.832paired t-test 2-sided
p-value: 0.392paired t-test 2-sided
p-value: 0.752paired t-test 2-sided
Primary

Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve Analysis

Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.

Time frame: 6-months from the index date (from January 1, 2009 to May 31, 2009; the index date was defined as the first date of oral triptan/sumatriptan-naproxen sodium prescription)

Population: The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.

ArmMeasureGroupValue (MEAN)Dispersion
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisTriptans349 United States dollarsStandard Deviation 396.4
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisNon-steroidal anti-inflammatory drugs11 United States dollarsStandard Deviation 69.8
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisOpioids49 United States dollarsStandard Deviation 621
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisErgots2 United States dollarsStandard Deviation 36.6
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisOther1 United States dollarsStandard Deviation 8.6
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisTotal412 United States dollarsStandard Deviation 757.7
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisOther1 United States dollarsStandard Deviation 7.2
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisTriptans397 United States dollarsStandard Deviation 418.9
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisErgots2 United States dollarsStandard Deviation 55.5
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisNon-steroidal anti-inflammatory drugs12 United States dollarsStandard Deviation 72.5
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisTotal466 United States dollarsStandard Deviation 687.7
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-naïve AnalysisOpioids54 United States dollarsStandard Deviation 509.5
p-value: <0.001paired t-test 2-sided
p-value: 0.177paired t-test 2-sided
p-value: 0.173paired t-test 2-sided
p-value: 0.191paired t-test 2-sided
p-value: 0.254paired t-test 2-sided
p-value: <0.001paired t-test 2-sided
Primary

Mean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch Analysis

Mean Total Cost was defined as the pharmacy cost plus the participant copay. Pharmacy costs were computed corresponding to the use of triptans, non-steroidal anti-inflammatory drugs, opioids, and other migraine therapy tablets (ergots and others). .Pharmacy cost plus participant copay was calculated as the mean of the total costs (pharmacy cost plus participant copay) of the five drug categories.

Time frame: 6-months from the index date (from January 1, 2009 to May 31, 2009; index date was defined as the first switch date to oral triptan/sumatriptan-naproxen sodium prescription)

Population: The SourceLx dataset from the family of Wolters Kluwer databases was used for this study. The database contains 30% of prescription claims filled in the United States, corresponding to approximately 160 million lives.

ArmMeasureGroupValue (MEAN)Dispersion
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisTriptans462 United States dollarsStandard Deviation 413.3
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisNon-steroidal anti-inflammatory drugs12 United States dollarsStandard Deviation 62.3
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisOpioids61 United States dollarsStandard Deviation 360.2
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisErgots3 United States dollarsStandard Deviation 51.9
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisOther1 United States dollarsStandard Deviation 8.5
Naïve - Sumatriptan/Naproxen SodiumMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisTotal537 United States dollarsStandard Deviation 564.2
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisOther1 United States dollarsStandard Deviation 6.1
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisTriptans496 United States dollarsStandard Deviation 439.9
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisErgots4 United States dollarsStandard Deviation 54.4
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisNon-steroidal anti-inflammatory drugs13 United States dollarsStandard Deviation 76.7
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisTotal576 United States dollarsStandard Deviation 736.2
Naïve - Oral TriptanMean Total Cost (Health Plan Plus Participant Copay Costs) Per Participant for Migraine-related Medications in 6-month Follow-up Period: Treatment-switch AnalysisOpioids62 United States dollarsStandard Deviation 547.4
p-value: <0.001paired t-test 2-sided
p-value: 0.146paired t-test 2-sided
p-value: 0.826paired t-test 2-sided
p-value: 0.354paired t-test 2-sided
p-value: 0.514paired t-test 2-sided
p-value: 0.001paired t-test 2-sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026